Multi-omics Characterization and Model Construction of Colchicine Anti-inflammatory Therapy Efficacy in ACS Patients (MCM-CATE-ACS)

Tongji University

Status: Enrolling

Conditions: ACS - Acute Coronary Syndrome

Treatments: Drug: Colchicine 0.5 MG Oral Tablet Once Daily

Study type: Interventional

Funder types: Other

Identifiers

NCT07064109

TJH-2025-07

Details and patient eligibility

About

The aim of this prospective cohort study was to investigate the multi-omics characteristics of the efficacy of colchicine treatment in patients with ACS and to construct a model of efficacy. The main questions the study aims to answer are

- Specific mechanisms of colchicine therapy in patients with ACS; Mechanism-based modelling to identify the population that benefits from colchicine treatment.

Enrollment: 380 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between the ages of 18 and 80
• ACS (STEMI or NSTE-ACS)
• Patients to receive standardised drug therapy
• Able and willing to provide informed consent

Exclusion criteria

• Any contraindication to colchicine or known intolerance to colchicine
• Has been using colchicine for a prolonged period of time for other medical conditions
• Women of childbearing age who are pregnant, breastfeeding or not using effective contraception
• Coronary artery bypass grafting within the last 3 years or planned
• Severe hepatic impairment: elevated serum alanine aminotransferase and/or aminotransferase (ALT) and/or aminotransferase (AST) levels of up to three times the upper limit of normal
• Severe renal impairment: eGFR <30mL/min/1.73m2
• Thrombocytopenia (platelet count less than 100*10⁹/L)
• Active diarrhoea
• Infectious diseases: presence of uncontrollable infectious diseases
• Immune-related diseases: known immune diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumours, etc.
• Strong CYP3A4 or P glycoprotein inhibitors (e.g., cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) are already in use and no alternative medications can be administered
• Planning to use systemic anti-inflammatory therapies such as NSAIDs, hormones, immunomodulators and chemotherapeutic agents

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

Colchicine treatment group

Experimental group

Description:

Adding low-dose colchicine on the basis of standardized treatment

Treatment:

Drug: Colchicine 0.5 MG Oral Tablet Once Daily

control group

No Intervention group

Description:

Standardized treatment